Colorectal cancer screening is one of the best proven and most cost-effective of all preventive interventions. Screening lowers both incidence and mortality. Bearing some of the costs of colonoscopy, also known as cost-sharing, has been a barrier to completion of colonoscopy, both as a primary screen and as a second test to complete screening after an abnormal initial stool or radiologic screening test. While a newly published model concludes that eliminating cost-sharing for colonoscopy after an initial screen is cost-effective, the desired outcome has already been achieved. The Centers for Medicaid and Medicare Services has announced the plan to eliminate this final out of pocket expense starting in 2023. While this is an important step, many barriers to screening for colorectal cancer and all other cancers remain. Eliminating downstream costs that result from an abnormal screen is a difficult to achieve but important goal.

See related article by Fendrick et al., p. 653

Sustained, well-coordinated efforts have resulted in remarkable progress toward the goal of reducing death and suffering from colorectal cancer in the United States. Colorectal cancer–specific mortality rates have dropped 60% in females since 1969 and 55% in males since 1978. Although declines in tobacco use and improvements in treatment have contributed to this mortality decline, colorectal cancer screening is responsible for most of this progress (1). Colorectal cancer screening is highly cost-effective because it can identify and remove polyps before they progress to cancer, thus negating the need for expensive treatment and lowering the incidence of colorectal cancer overall (2). However, timely and equitable diagnostic and therapeutic follow-up is required for the benefits of screening to be achieved.

A great many organizations from every sector of society have joined together to drive colorectal cancer screening rates higher. The 80% by 2018 campaign, launched in 2014 by the National Colorectal Cancer Roundtable (NCCRT), the American Cancer Society and the Centers for Disease Control and Prevention, was one of the most successful cancer-related public health efforts in U.S. history, contributing to a steady increase in screening rates (3). In fact, at the end of 2018, screening rates for the 65–74 years old population reached an unprecedented 79.3%, and many Medicare-insured subgroups, such as women, hit the 80% goal (4). The NCCRT has built upon this work and launched the 80% in Every Community campaign, an effort specifically focused on overcoming barriers for individuals and populations that historically face more obstacles to colorectal cancer screening. Many of those obstacles are linked to ensuring access to colonoscopy, the ultimate step in any screening pathway. For some people, the fear of being responsible to pay some or all of the cost of colonoscopy due to lack of health insurance or inadequate insurance coverage has a particularly chilling effect on participation. Historically, even relatively low out of pocket assignment of expenditure dissuades many people from seeking or completing preventive care (5–7). Deductibles and co-pays for colonoscopy can be substantial, and differentially impact those populations at greatest risk for inequities in care. Accordingly, it is not surprising that eliminating out of pocket spending for colonoscopy has been a key public health advocacy strategy to enable more people to be screened for colorectal cancer.

Many people opt to be screened with colonoscopy without undergoing a noninvasive test first. For everyone else, an abnormal initial test, such as a fecal immunochemical stool test (FIT) or a FIT-DNA stool test, requires that a colonoscopy be performed to complete the screening process. Greater focus is being given to the unfortunate reality that, without specific interventions, 50% or less of individuals with an abnormal FIT or FIT-DNA, all of whom have a relatively high likelihood of harboring an advanced polyp or early cancer, never have a colonoscopy (8, 9). One of the reasons that has been identified for this shortfall is that many patients, even those with Medicare or commercial insurance, receive a charge for the test in the form of a deductible, co-pay, or both. This “cost-sharing” can easily reach $100s or even $1000s, which can create substantial and long-term financial consequences for patients.

In this issue of Cancer Prevention Research, Fendrick and colleagues apply a highly reliable and valid colorectal cancer screening model to conclude that eliminating cost-sharing for colonoscopy following an abnormal initial screen is very likely to be cost-effective, even if the increased uptake of colonoscopy is very small (10). It is safe to say that the major audiences for this study are decision-makers at the Centers for Medicare and Medicaid Services (CMS) and advocacy groups that work to inform CMS. The publication of this article is, happily, several weeks too late! On July 7, leaders at CMS notified colorectal cancer screening advocates throughout the country that they are proposing to eliminate cost-sharing for colonoscopies following noninvasive testing, effective January 2023. With this policy change, very few patients with any type of insurance will be subject to sharing the cost of the test regardless of whether they had a noninvasive test first or whether a biopsy is performed.

The key policy accomplishment that led to this CMS policy change was passage of the Removing Barriers to Colorectal Screening Act which eliminated the “colonoscopy surprise”—the conversion of a screening colonoscopy into a diagnostic colonoscopy if a biopsy is performed. Without the Act, only patients with a normal colonoscopy, the very patients who experience no benefit from the test, would undergo colonoscopy without having to share in payment.

Patients with polyps or early cancers, or anyone having a biopsy for that matter, would still be charged co-pays and deductibles. This recent CMS decision reflects the agency's recognition that, now that the colonoscopy surprise has been legislated away, it was time to eliminate the final policy-level cost barrier to colorectal cancer screening in Medicare recipients. This latest move proves that CMS administrators and colorectal cancer screening advocates share the same goal of increasing colorectal cancer screening for all Medicare recipients.

As of 2023, one of the primary goals of the colorectal cancer screening advocacy community will have been nearly completely achieved. Not only will cost-sharing be eliminated for patients with government-issued insurance, most patients insured by commercial products will also enjoy this benefit. Through the recent changes in Medicare and a series of executive clarifications following the passage of the Affordable Care Act almost all insured patients should be free from deductibles or co-pays regardless of whether a colonoscopy is performed initially or after a noninvasive screen and regardless of whether a biopsy is performed. More people will be screened and fewer people will develop colorectal cancer or die from this disease.

Policy-level barriers to care are historically the most difficult to change and often have the most far-reaching impact. The elimination of cost-sharing at the policy-level should not be under appreciated; however, many other barriers to colorectal cancer screening remain, and they will persist after the removal of cost-sharing without concerted efforts on the part of everyone dedicated to increasing access to screening. Access to care and particularly to colonoscopy, transportation, needing to take time off from work to complete a colonoscopy, and fear of testing and cancer treatment will continue to be barriers for some adults, particularly those who live with sources of inequities. Efforts must be made to ensure that patients now know that cost-sharing has been removed.

At the implementation and system level, one lingering challenge that is likely to contribute to needless cost-sharing is miscoding of colonoscopy (11). Numerous colonoscopy codes exist and coding systems often automatically generate the “correct” code based on colonoscopy findings. Colonoscopy care teams, including billers, will need to commit to understand and implement the correct approach to billing and work with IT teams to modify billing-generating components of EMR's. Colonoscopy billing must reflect the indication for the procedure, not the result of the exam.

Inspired by the colorectal cancer screening policy successes, some experts and advocates have called for elimination of out of pocket expenses associated with the diagnostic cascade following all initial cancer screens, including mammography and lung CT. Unfortunately, the rationale and arguments that ultimately led to eliminating colorectal cancer screening co-pays, will not work for other cancer screens. Colonoscopy is absolutely unique among cancer screening tests. It can be used as either a one-step or two-step procedure and simultaneously achieves screening, diagnostic, and therapeutic goals. Colorectal cancer screening actually prevents many cases of colorectal cancer, a far more cost-effective strategy than exclusively detecting cancers, which leads to costly treatments. No other downstream test following an abnormal initial screen for breast, prostate, or lung cancer simultaneously diagnoses and prevents cancer. None of the downstream tests are also recommended as stand-alone screens. Downstream costs in the diagnostic cascade following initial screens are a serious barrier to care; eliminating them will require new and unique legislative solutions. The series of legislative and administrative decisions that have now eliminated out of pocket charges resulting from colorectal cancer screening for all insured patients will not work for other cancer screening strategies—another pathway forward to achieve equitable screening will be needed.

While the cancer care community continues to work to reduce barriers to cancer care, this is a good time to recognize that colleagues at CMS have been real partners in promoting colorectal cancer screening. To our colleagues at CMS, a heartfelt thank you for eliminating one more barrier to colorectal cancer screening. The colorectal cancer advocacy community can now turn its attention to effective interventions and foundational policy changes that will provide access and care for all patients, from screening through treatment.

K.A. Rendle reports grants from NIH/NCI during the conduct of the study; grants from Pfizer and AstraZeneca, and personal fees from Merck outside the submitted work. No disclosures were reported by the other author.

R.C. Wender: Conceptualization, writing–review and editing. K.A. Rendle: Conceptualization, writing–review and editing.

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